FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine resign their posts in the wake of their Office havi...
Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studies.
A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...
Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approval...
Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead...
QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Cheetah) based on conce...
Researchers publish two journal articles relating to rare disease drug development.
Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.
